PET Imaging Study of Recovered Anorexics

Not Applicable

Completed

• Conditions: Anorexia Nervosa
• Interventions: Drug: Fluoxetine

• Registration Number: NCT00603018
• Lead Sponsor: University of Pittsburgh

Brief Summary

Several studies in the past suggest that individuals who have or had anorexia nervosa may have alterations in brain serotonin. Serotonin seems to play an important role in regulating anxiety, mood, and other symptoms found in anorexia nervosa. We will be using a technology called Positron Emission Tomography (PET), which is a method used to take pictures of the body, in this case, the brain. Study participants will undergo two baseline PET scans on the first day of the study. The women who have recovered from anorexia will then be given a medication called fluoxetine (also know as Prozac) to take for 8 weeks. At the end of the 8th week, they will return for a third PET scan. By comparing the brain scans, before and after fluoxetine treatment, we can understand more about how treatment with fluoxetine affects the serotonin receptors in the brain. We will be comparing brain serotonin system in women who have recovered from anorexia before and after medication in order to gain a better understanding of changes in the serotonin system associated with eating disorders. This study may help shed light on how to make fluoxetine a more effective treatment for anorexia nervosa.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2008-01-26
• Study First Posted: 2008-01-28
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2016-01-25
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-02
• Last Update Submitted: 2016-08-02
• Results First Posted: 2016-09-23
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

• Recovered from Anorexia Nervosa
• Not taking medication for emotional problems
• Regular menstrual cycle

Exclusion Criteria

• Women who are pregnant or nursing
• Psychoactive medications in the past 30 days
• Neurological disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Annorexia nervosa	Fluoxetine	Participants recovered from anorexia nervosa before and after administration of fluoxetine

Primary Outcome Measures

Name	Time	Method
Serotonin Receptor 1A Binding Potential In Regions of Interest (ROI) Accounting for Binding Potential in a Region Without Serotonin 1A Receptors	Baseline and 8 weeks	We used PET and \[11C\]WAY to assess 5-HT1A binding potential (BP) = \[11C\]WAY 100635 BP = Distribution Volume (DV)ROI-DVcerebellum in striatal regions; subcortical regions including insula, medial temporal lobe, amygdala, hippocampus, midbrain, parahippocampal gyrus; and the neocortical regions (i.e., anterior cingulate cortex). Analysis of the PET data was performed using the Logan graphical method (Logan et al. 2001) with the cerebellum as a reference region for non-displaceable uptake. 23 REC AN were studied. The Binding Potential (BP) was calculated as followed: BPP = fP Bavail/KD = VT-VND;(Abbrev.: BPP = In vivo binding potential; fP = free fraction in plasma; Bavail = Density of receptors available to bind radioligand in vivo; KD = Dissociation Constant; V = Volumes of Distribution expressed relative to total plasma ligand concentration; T = Total radioligand in tissue; ND = Nondisplaceable tissue uptake; see Innis et al. 2007); Units: mL cm -3

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States